Improving Access to Early Psychosis Coordinated Specialty Care

Improving Access to Early Psychosis Coordinated Specialty Care Services

The aim of this study is to evaluate the feasibility of developing an Early Psychosis CSC service delivery model suitable for rural settings in NC. Major challenges to delivery of specialized health care services for persons in the early stages of psychosis include the high level of provider expertise and the frequency and intensity of services. These challenges limit the feasibility of brick-and-mortar programs to serve individuals living in rural settings. This study proposes to expand service delivery methods to include telehealth as a potential solution.

Study Overview

• Status: Completed
• Conditions: Psychosis
• Intervention / Treatment: Other: Telehealth

Detailed Description

The UNC OASIS program currently provides evidenced-based outpatient coordinated specialty care services (CSC) to persons within the first five years of a psychotic disorder. Medical management and psychotherapy services are mainly provided in brick and mortar offices. Supported education, supported employment, and peer support services are provided in offices and also in the community. The service model is relatively intense, involving treatment sessions up to several times a week. Thus a barrier to persons in rural North Carolina receiving CSC services is the time taken to travel to office based appointments.

The purpose of this study is to determine feasibility and acceptability of providing some of the services provided by OASIS via telehealth.

Participants: Up to 10 patients who have been accepted by the OASIS program and who live 45-minutes or more from the UNC OASIS program or another CSC program. Participants must also have home internet bandwidth sufficient to support the telehealth platform and own a computer or other device (smart phone, tablet, etc.) compatible with the telehealth platform.

Procedures (methods): The OASIS program does not exclude patients based on where they live in North Carolina. Potential OASIS patients and their families participate in an initial psychosocial and medical evaluation. At this time the OASIS program director reviews the OASIS program expectations with the patient and family. If the OASIS program and the patient and the patient's family member agree that the OASIS program is a good fit, the patient is then accepted into the program. After acceptance into the OASIS program patients who live 45 minutes or more away from the UNC OASIS or another CSC program and who reside in North Carolina will be informed about the availability of the telehealth pilot project by the OASIS program director.

UNCH has developed a telehealth service that is provided via the UNC electronic medical record platform, EPIC. If interested, the OASIS patient and their family member will meet with a study staff person, who will evaluate whether their internet bandwidth is sufficient to support the EPIC telehealth platform and if they own a computer or other device that supports the EPIC telehealth platform. Patients who are interested and who meet these requirements will then participate in the oral and written informed consent process.

Participants who consent to participate in the study will receive some of their CSC services via telehealth, and will continue to receive some of their services in the OASIS offices. During this pilot phase the project will be flexible about the relative proportion of services delivered via telehealth and in-person. The main study participant is the patient, however since family therapy may be delivered via telehealth interested family members are also asked to consent to study participation.

The OASIS program routinely collects quality assurance data via self-report and clinician-administered assessments. The study will obtain consent from study participants to access this information. In addition to the Quality Assurance document patients who are subjects and their family members who also consent to participate in the the telehealth pilot project will also complete a self-report survey inquiring about their satisfaction with telehealth services.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • OASIS Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 36 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-36
• Reside in NC
• Live more than a 45 minute drive from UNC OASIS or UNC Encompass CSC programs.
• Accepted into the OASIS program.
• Have access to a computer or other device with broadband internet sufficient to support the EPIC-delivered telehealth services.
• Willing to receive some services via telehealth. A family member of a patient who is participating in this research study.

Exclusion Criteria:

• Not age 18-36
• Does not reside in NC
• Live within a 45 minute drive from UNC OASIS or UNC Encompass CSC programs.
• Not accepted into the OASIS program.
• No access to a computer or other device with broadband internet sufficient to support the EPIC-delivered telehealth services.
• Not willing to receive any services via telehealth

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: OASIS Clients; Clients of the OASIS Program who live at least 45 minutes away from an Early Psychosis Coordinated Specialty Care Program and are willing to engage in some of their services through telehealth.	Other: Telehealth; Early Psychosis Coordinated Specialty Care Services via telehealth.; Other Names: Video visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Telehealth Healthcare Service Satisfaction and Usability Score (Month 3)	The UNC OASIS Telehealth Satisfaction and Usability Survey is a self-report measure with 8 items assessing satisfaction with aspects of telehealth service delivery. Items using 5-item likert scale ranged from Strongly agree to Strongly disagree. Items include: 1) sessions ran smoothly, 2) preference for in-person or telehealth service or no preference, 3) comfortable using telehealth technology, 4) technical difficulties encountered (5-item likert ranging from Never to Often), 5) privacy/confidentiality of telehealth as either better than/same as/not as good as in-person visits and any comments, 6) comfort level communicating to staff using telehealth, 7) whether telehealth made attending appointments easier/same as/more difficult than in person visits, 8) whether would use telehealth services again. Lower scores reflect higher satisfaction.	3 months
Mean Telehealth Healthcare Service Satisfaction and Usability Score (Month 6)	The UNC OASIS Telehealth Satisfaction and Usability Survey is a self-report measure with 8 items assessing satisfaction with aspects of telehealth service delivery. Items using 5-item likert scale ranged from Strongly agree to Strongly disagree. Items include: 1) sessions ran smoothly, 2) preference for in-person or telehealth service or no preference, 3) comfortable using telehealth technology, 4) technical difficulties encountered (5-item likert ranging from Never to Often), 5) privacy/confidentiality of telehealth as either better than/same as/not as good as in-person visits and any comments, 6) comfort level communicating to staff using telehealth, 7) whether telehealth made attending appointments easier/same as/more difficult than in person visits, 8) whether would use telehealth services again. Lower scores reflect higher satisfaction.	6 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Substance Abuse and Mental Health Services Administration (SAMHSA); North Carolina Department of Health and Human Services
• Investigators: Principal Investigator: Diana Perkins, MD, MPH, University of North Carolina, School of Medicine, Department of Psychiatry

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 27, 2019
• Primary Completion (ACTUAL): September 27, 2020
• Study Completion (ACTUAL): September 27, 2020

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (ACTUAL): February 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Telehealth; Specialty Care; Rural Initiative
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 19-0048; 3B09SM010032-19S3 (SAMHSA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: 9-36 months following publication
• IPD Sharing Access Criteria: IRB/IEC/REB approval and executed data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No